Regulatory Affairs Manager

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

Regulatory Affairs Manager
Location: Uppsala, Sweden (hybrid)

We are now expanding our Regulatory Team in Uppsala and looking for a Regulatory Affairs Manager to take on a role within the Toxins Regulatory Strategy team.

You will work with and guide the project´s expert functions to deliver dossier documents and ensure that planned submissions of marketing applications for our new product are complete, compliant, and performed per agreed timelines. Beyond this, you will monitor archives and regulatory work procedures, assuring that our new product remains compliant with corporate SOPs and global regulatory guidance.

Key Responsibilities:

* Be co-responsible for global regulatory strategies during the development, pre-submission, evaluation, and post-approval phases, with an emphasis on Europe.
* Work with Marketing, Clinical, Non-clinical, CMC, Operations and other company functions, to align the overall RA submission strategies.
* Act as a key member of the toxin global regulatory affairs team, providing input for team goals, norms, responsibilities, and communication plans. Coordinate timelines and deliverables for activities and documents included in the planned submission dossiers.
* Contribute to keeping archives and regulatory work procedures up to date.
* Maintain a proactive mindset to identify and assess risks associated with product development/life cycle management and recommend strategies to mitigate these risks.
* Provide regular updates to toxins global regulatory lead as required.

Skills & Qualifications:

* University degree in a life science area
* Experience within Regulatory Affairs in Life Science
* Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development in multiple key regions, with a focus on Europe.
* Previous experience from pharmaceutical registration procedures
* English (fluent) and Swedish (advantage)

As a person, you are open-minded and willing to adapt to changes and enjoy working with others in a collaborative way, also across several cultures. You are self-driven, flexible, methodical, with the ability to structure work and manage multiple requests while maintaining timelines.

What we offer in return
You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 450 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.

We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10 minute bike ride from Uppsala Central Station.

Your application
We welcome your application (CV and letter) via our company website CAREERS | Galderma. Apply as soon as possible though no later than the 19th of February 2023. The selection process is ongoing and the role may be filled prior the last application date.

About the company
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven innovative solutions for the skin. For more information, please visit www.galderma.com.